Brandwood CKC Joins PharmaLex

Brandwood CKC has merged with international equivalent PharmaLex, opening the way for Australian life science companies to access broader global markets.

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Australia’s TGA releases updated Essential Principles Checklist

In Australia, for any given device, irrespective of risk classification, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) essential principles. The essential principles...

FDA & “Certain Devices” with Intact Skin Contact – Draft Guidance Assessment

The human body’s biggest organ is the skin. It is also our best organ because it keeps the outside out and our insides in. Yet,...
Doctor giving medicine

It’s all about Access!

In Australia, there are a number of options where patients can gain access to products that have not been approved for use. Some of these...

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